• Full Prescribing Information, including BOXED WARNINGS
  • Medical Information
  • Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve.

    Click here to learn how we are responding.

    Pfizer is building onto the clinical experience of trastuzumab

    TRAZIMERA is a biosimilar* to Herceptin® (trastuzumab) that was approved by the FDA based on the totality of evidence1,2

    TRAZIMERA offers the potential to help address treatment costs and shows no clinically meaningful differences to Herceptin1-3

    TRAZIMERA is available in single- and multiple-dose options​​​​​​​1

    Approved across all indications of Herceptin, with identical dosing​​​​​​​1

    See dosing & product info

    88% of commercially insured patients have access to TRAZIMERA nationwide​​​​​​​3‡

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    FDA-approved biosimilars such as trastuzumab-qyyp (TRAZIMERA™) are recommended as treatment options in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)4,5§

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    Helpful support for your patients and practice is available

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    Pfizer Oncology Together™ Co-Pay Savings Program for Injectables

    Eligible,|| commercially insured patients may pay as little as $0 per TRAZIMERA treatment.See full Terms and Conditions below.

    • This program covers up to $25,000 per calendar year**
    • There are no income requirements for patients to qualify
    • For information on enrollment, claims submissions, and reimbursement, visit PfizerOncologyTogether.com to download the Co-Pay Savings Program Brochure
    FOR LIVE, PERSONALIZED SUPPORT
    Call 1-877-744-5675 (Monday—Friday 8 AM —8 PM ET)
    Learn more about the program

       *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar and the reference product.

       WAC is a manufacturer's undiscounted or list price to wholesalers/direct purchasers and, therefore, is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations. Data as of February 2020.

       ‡Medical policy data are current as of February 2021. Please verify patient benefits to confirm coverage.

       §NCCN Guidelines® recommend the use of an FDA-approved biosimilar as an appropriate substitute for trastuzumab. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
    ​​​​​​​
    ​​​​​​​

        ||Terms and Conditions
    ​​​​​​​
    By using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions below:

    • The Pfizer Oncology Together Co-Pay Savings Program for Injectables for TRAZIMERA is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
    • Program offer is not valid for cash-paying patients.
    • With this program, eligible patients may pay as little as $0 co-pay per TRAZIMERA treatment, subject to a maximum benefit of $25,000 per calendar year for out-of-pocket expenses for TRAZIMERA including co-pays or coinsurances.
    • The amount of any benefit is the difference between your co-pay and $0.
    • After the maximum of $25,000 you will be responsible for the remaining monthly out-of-pocket costs.
    • Patient must have private insurance with coverage of TRAZIMERA.
    • This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs.
    •  You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
    • You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required.
    • You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs.
    • This program is not valid where prohibited by law.
    • This program cannot be combined with any other savings, free trial or similar offer for the specified prescription.
    • This program is not health insurance.
    • This program is good only in the U.S. and Puerto Rico.
    • This program is limited to 1 per person during this offering period and is not transferable.
    • No other purchase is necessary.
    • Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you.
    • Pfizer reserves the right to rescind, revoke or amend this program without notice.
    • This program may not be available to patients in all states.
    • For more information about Pfizer, visit www.pfizer.com.
    • For more information about the Pfizer Oncology Together Co-Pay Savings Program for Injectables, call 1-877-744-5675, or write to
      Pfizer Oncology Together Co-Pay Savings Program for Injectables
      P.O. Box 220366
      ​​​​​​​Charlotte, NC 28222
    • ​​​​​​​Program terms will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.

      For patients to be eligible for the Injectables Co-Pay Program for TRAZIMERA, they must have commercial insurance that covers TRAZIMERA and they cannot be enrolled in a state or federally funded insurance program. Whether a co-pay expense is eligible for the Injectables Co-Pay Program for TRAZIMERA benefit will be determined at the time the benefit is paid. Co-pay expenses must be in connection with a separately paid claim for TRAZIMERA administered in the outpatient setting.

    ​​​​​​​   #The Injectables Co-Pay Program for TRAZIMERA will pay the co-pay for TRAZIMERA up to the annual assistance limit of $25,000 per calendar year per patient.

    ​​ **The Injectables Co-Pay Program for TRAZIMERA provides assistance for eligible, commercially insured patients prescribed TRAZIMERA for co-pays or coinsurance incurred for TRAZIMERA up to $25,000 per calendar year. It does not cover or provide support for supplies, services, procedures, or any other physician-related services associated with TRAZIMERA treatment.

    ​​​​​​​


    References:
    1. TRAZIMERA [prescribing information]. New York, NY: Pfizer Inc.; November 2020.
    2. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: FDA, US Dept of Health and Human Services; April 2015. https://www.fda.gov/media/82647/download. Accessed February 22, 2021.
    3. Data on file. Pfizer Inc., New York, NY.
    4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © 2020 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
    5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2020. © 2020 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.

    IndicationS

    Adjuvant Breast Cancer

    TRAZIMERA is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature*) breast cancer:​​​​​​​

    • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
    • As part of a treatment regimen with docetaxel and carboplatin
    • As a single agent following multi-modality anthracycline based therapy

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    *High risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

    Metastatic Breast Cancer

    TRAZIMERA is indicated:

    • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
    • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    Metastatic Gastric Cancer

    TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    BOXED WARNINGS AND ADDITIONAL IMPORTANT SAFETY INFORMATION

    Cardiomyopathy

    • Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens
    • Evaluate left ventricular function in all patients prior to and during treatment with TRAZIMERA. Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left ventricular function

    Infusion Reactions; Pulmonary Toxicity

    • Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt TRAZIMERA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

    Embryo-Fetal Toxicity

    • Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception

    Cardiomyopathy

    • Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy
    • Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
    • Trastuzumab products can also cause asymptomatic decline in LVEF
    • Discontinue TRAZIMERA treatment in patients receiving adjuvant breast cancer therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left ventricular function

    Cardiac Monitoring

    • Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of TRAZIMERA
    • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
    • Monitor frequently for decreased left ventricular function during and after TRAZIMERA treatment
    • Monitor more frequently if TRAZIMERA is withheld for significant left ventricular cardiac dysfunction

    Infusion Reactions

    • Administration of trastuzumab products can result in serious and fatal infusion reactions
    • Symptoms usually occur during or within 24 hours of administration of trastuzumab products
    • Interrupt TRAZIMERA infusion for dyspnea or clinically significant hypotension
    • Monitor patients until symptoms completely resolve
    • Discontinue TRAZIMERA for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
    • Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

    Embryo-Fetal Toxicity

    • Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
    • Verify the pregnancy status of females of reproductive potential prior to the initiation of TRAZIMERA
    • Advise pregnant women and females of reproductive potential that exposure to TRAZIMERA during pregnancy or within 7 months prior to conception can result in fetal harm
    • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of TRAZIMERA
    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for TRAZIMERA treatment and any potential adverse effects on the breastfed child from TRAZIMERA or from the underlying maternal condition

    Pulmonary Toxicity

    • Administration of trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
    • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
    • Discontinue TRAZIMERA in patients experiencing pulmonary toxicity

    Exacerbation of Chemotherapy-Induced Neutropenia

    • In randomized, controlled clinical trials, the numbers of per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

    Most Common Adverse Reactions

    • The most common adverse reactions associated with trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
    • The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

    ​​​​​​​Adjuvant Breast Cancer

    TRAZIMERA is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature*) breast cancer:

    • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
    • As part of a treatment regimen with docetaxel and carboplatin
    • As a single agent following multi-modality anthracycline based therapy

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    *High risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

    ​​​​​​​Metastatic Breast Cancer

    TRAZIMERA is indicated:

    • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
    • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    Metastatic Gastric Cancer

    TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

    Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

    Please see full Prescribing Information, including BOXED WARNINGS.

    TRAZIMERA is a trademark of Pfizer Inc.

    Herceptin is a registered trademark of Genentech, Inc.